Multifocal lens having an optical add power progression, and a system and method of providing same
11506914 · 2022-11-22
Assignee
Inventors
- Carmen Canovas Vidal (Groningen, NL)
- Marrie H. Van Der Mooren (Engelbert, NL)
- Hendrik A. Weeber (Groningen, NL)
Cpc classification
A61F2/1616
HUMAN NECESSITIES
International classification
Abstract
An apparatus, system and method including an ophthalmic lens having an optic with an anterior surface, a posterior surface, and an optical axis. The ophthalmic lens further includes a first region having a first optical power and a second region having a second optical power. The ophthalmic lens further includes a third region having an optical power that progresses from the first optical power to the second optical power. The progression may be uniform or non-uniform. Each of the first, second and progression optical power may include a base power and an optical add power. Each of the first, second and progression regions may provide a first focus, a second focus and a plurality of third foci, respectively.
Claims
1. A treatment method comprising: assessing, with a biometric reader, biometric measurements of a subject eye; designing, based on the biometric measurements, a set of intraocular lenses each having the same base power and optical add power, with differing optical add power progressions, the optical add power progression of each intraocular lens of the set of intraocular lenses being non-concentric with the intraocular lens and being between two zones each having a constant optical add power; selecting the intraocular lens containing the optical add power progression that provides enhanced optical performance of the subject eye based on simulations including the biometric measurements of the subject eye and configurations of each intraocular lens of the set of intraocular lenses; and implanting the intraocular lens in the subject eye.
2. The method of claim 1, further comprising simulating aberrations effectuated by the optical add power progression of each intraocular lens of the set of intraocular lenses based on the biometric measurements of the subject eye, and wherein the selecting the intraocular lens is based on the aberrations.
Description
BRIEF DESCRIPTION OF THE FIGURES
(1) Embodiments of the present invention will be understood with reference to the detailed description in conjunction with the accompanying figures, in which like numerals indicate like aspects, and wherein:
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(14)
(15)
(16)
(17)
(18)
(19)
(20)
(21)
DETAILED DESCRIPTION
(22) It is to be understood that the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a clear understanding of the present invention, while eliminating, for the purpose of clarity, many other elements found in typical implantable optic apparatuses, systems and methods. Those of ordinary skill in the art may thus recognize that other elements and/or steps are desirable and/or required in implementing the present invention. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the present invention, a discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications to the disclosed elements and methods known to those skilled in the art.
(23) The present invention is directed to apparatuses, systems and methods for providing and/or designing a multifocal ophthalmic lens, such as a multifocal intraocular lens (IOL), that provides varied optical power to enhance vision for different focal distances. The terms “power” and “optical power”, as used herein, are defined to include the capability of an optical surface to redirect incident light to a focal point. The optical power may result from reflection, refraction, diffraction, or some combination thereof, and is generally expressed in units of Diopters.
(24)
(25) A first portion 27 of the incident light 26 may be substantially unaffected by zones 23, or may be affected by some of zones 23, and may be focused to produce a first focus 29 approximately located on a retina 30 of the eye 22. This first focus 29 provides distant vision. A second portion 32 of the incident light 26 may form a second focus 34, located in front of the retina. IOL 20 thus effectively has at least two optical powers due to the combination of the anterior surface 24, the posterior surface 28, and zones 23.
(26) As used herein, the term “near vision’ generally corresponds to vision provided when objects are at a distance between about 25 cm to about 50 cm. Conversely, the terms “distance vision” and “distant vision,” as used herein, refer to vision wherein objects viewed are relatively far from the subject. The terms “distance vision” and “distant vision” may thus generally correspond to vision provided when objects are at a distance of at least about 2 meters or more away from the subject. The term “intermediate vision” refers herein to the viewing of objects at a distance between near vision and distant vision.
(27)
(28)
(29) Lens 20 may be an intraocular lens for placement in either the posterior or anterior chamber of a subject eye. As such, lens 20 may be used to replace the natural lens of the eye, such as after removal of the natural lens during cataract surgery. Alternatively, the lens 20 may be a phakic lens disposed in front of the iris, behind the iris, or in the plane defined by the iris. Alternatively, lens 20 may be a corneal implant. Alternatively, lens 20 may be a contact lens or the like used to provide or improve vision.
(30) Lens 20 may be constructed of any commonly employed material or materials used for optics, such as polymethylmethacrylate (PMMA), silicone polymeric materials, acrylic polymeric materials, hydrogel-forming polymeric materials, such as polyhydroxyethylmethacrylate, polyphosphazenes, polyurethanes, mixtures thereof, and the like. The construction material preferably is capable of providing the requisite vision or vision correction, and exhibits biocompatibility with the eye. Lens 20 may be made of or contain photosensitive materials (e.g., photopolymer or silver halide) or a variable refractive index material.
(31) Foldable/deformable materials are particularly advantageous for use in or as lens 20 and/or optic 45, since such deformable materials may be rolled, folded or otherwise deformed and inserted into the eye through a small incision. The lens material preferably has a refractive index allowing a relatively thin, and preferably flexible, optic 45, for example, having a thickness in the range of about 100 microns to about 1000 microns, and preferably about 150 microns to about 500 microns. In embodiments wherein lens 20 is an intraocular lens, optic 45 may have a diameter of about 2 mm or less to about 7 mm or more, and preferably of about 4.0 mm to about 6.0 mm or about 6.5 mm.
(32) In an exemplary embodiment, lens 20 may comprise one or more fixation and/or support members, or “haptics.” Haptics 47 may be made of the same material as optic 45 and/or may be integrally formed with optic 45. Alternatively, one or more haptics 47 may be formed separately and attached to optic 45. Haptics 47 may comprise any of a variety of materials that exhibit sufficient supporting strength and resilience, and/or that are substantially biologically inert in the intended in vivo or in-eye environment. Suitable materials for this purpose include, for example, polymeric materials such as silicone polymeric materials, acrylic polymeric materials, hydrogel-forming polymeric materials, such as polyhydroxyethylmethacrylate, polyphosphazenes, polyurethanes, mixtures thereof, and the like.
(33) As illustrated in
(34) The annular zones 130, 134 are preferably concentrically offset in the IOL plane so as to form optical add power steps between adjacent zones 130, 134, the steps being selected to produce a predefined relationship between each of the annular zones 130, 134. In certain embodiments, the zones 130 are formed by refractive index variations between the central zone 134 and the other zones 134. Preferably in the embodiment of
(35) However, the abrupt changes in the optical add power steps between different zones 130, 134 of the lens 20 typically generate glare and/or halos, with loss in contrast sensitivity. This is amplified when diffraction is used to generate an extra foci due to the amount of light that is lost in diffraction orders other than those used to achieve multifocality. In addition, intermediate vision is not adequately provided by these types of designs, in part because the design is for enhancing only near and far vision.
(36) To remedy these disadvantages of the prior art, the present invention provides a design with at least three different zones that provide multifocal vision. An exemplary embodiment is presented in
(37) Zones 220, 210, 230 are distinct from zones 130, 134, at least in that there is no abrupt change in optical power as between illustrated central zone 210 and zones 220, 230. More particularly, the optical add power progressively varies across at least a portion of lens 20, and such progression may occur concentrically outward from the center point of central zone 210, vertically from a top portion to a bottom portion of the optic of lens 20 as that lens resides in situ, horizontally from a right to left portion of the optic of lens 20 as that lens resides in situ, and/or in any combinations thereof.
(38) By way of example, when the design is applied vertically, lens 20 may have an optic with a particular diameter, such as 6 mm. From the top of the optic as the optic is positioned in situ, at 37.5% from the topmost point along the vertical diameter, or 2.25 mm along the vertical diameter from the top of a 6 mm diameter exemplary optic, 0 Diopters of optical add power may be provided for all horizontal cross sections across optic 45. For the next 2.25 mm along the vertical diameter of an exemplary 6 mm diameter optic, the optical add power may vertically progress from 0 Diopters to, for example, about +3 Diopters. Along the lowermost portion of optic, such as the lowermost 25% along the vertical diameter (i.e., the lowermost 1.5 mm of the vertical diameter of an exemplary 6 mm diameter optic 45), the optical add power may remain constant, such as at +3 Diopters, for example, or alternatively may follow a secondary progression. The vertical progression(s) may progress at a substantially uniform, constant rate, or may progress at varying rates.
(39) The zone 210 is designed to be non concentric with respect the optic. Considering the 3 mm inner part of the optic, the 25% is included in the zone 220 while the remaining 75% is inside of the zone 210.
(40) For the sake of clarity, as used herein the optical add power is the additional optical power provided in conjunction with a base power for the optic. Of course, those skilled in the art will appreciate, in light of the discussion herein, that the base power of the optic may be calculated in order to achieve emmetropia for far distances.
(41) For a determined regional power distribution, the method by which the power progresses can be defined as follows. In an embodiment, assuming a constant progression of power between the designed for boundaries of optical add power, the horizontal cross-sectional add power in this illustrative 6 mm diameter optic embodiment may follow the equation:
0 D 0<y′<2.25 mm
1.33*(y′−2.25)D2.25<y′<4.5 mm
3D y′>4.5 mm
(42) where y′ is the distance from reference 0 mm at the top of the vertical diameter of the optic. Thus, the add power along a horizontal cross section through the center point of optic (i.e., where y′=3) is, in this exemplary embodiment:
(43) 1.33*(3-2.25)=1.00 D. In alternative embodiments, y′ may be measured from other points at the edge of the optic, e.g. at the far right point of the horizontal diameter of the optic.
(44) The same horizontal cross sectional add power may be expressed by measuring the vertical distance from the center of the lens:
0D−3<y<−0.75 mm
1.33*(y+0.75)D−0.75<y<1.5 mm
3D y>1.5 mm
where y represents the vertical distance with respect to the center of the lens. Such a power distribution is identical to that previously presented.
(45) In another embodiment with the same regional power distribution, the method of designing the progression might be imposed by a step function. In that case, the power may be as follows:
+0D 0<y′<2.25 mm
+1D 2.25<y′<3.375 mm
+2D 3.375<y′<4.5 mm
+3D 4.5<y′<6 mm
when the vertical distance (y′) is measured from the uppermost part of the lens or:
+0D−3<y<−0.75 mm
+1D−0.75<y<0.375 mm
+2D 0.375<y<1.5 mm
+3D 1.5<y<3 mm
when y represents the vertical distance to the center of the lens.
(46)
(47) The tangential sag defined in such a way may be then fitted according to (eq 1):
(48)
Therefore, the vertical meridian of the lens is defined according to an extended aspheric shape, with a curvature c and a conic constant k, although other symmetrical or non symmetrical terms (k1 until k8) are considered in order to achieve the fitting of the corresponding surface. The exemplary embodiment showed in
(49)
Thus, the curvature and conic constant used for fitting the tangential sag are also considered in generating the corresponding meridional sag, which is defined as a standard aspheric surface, defining the combination of the complete surface of the lens.
(50) The optical behavior of such a design can be computationally tested. Those skilled in the art will appreciate that, for example, an optical design software simulation may be employed in order to provide such modeling, for example, using Zemax® software by Zemax Development Corporation of Bellevue, Wash. A computational model of an average eye may be used in order to evaluate the performance of the design. This computational model may comprise the most representative optical structures of the eye, such as the cornea, the pupil and the retina. Average corneal aberrations may also be considered in order to further mimic the average eye. An IOL with a determined design may be inserted in such a model and different optical quality parameters may be calculated. Those calculations may be performed in white light conditions to closely represent the real behavior of the design, once implanted into the eye.
(51)
(52) The optical quality of the eye containing the progressive design may also be assessed by the eye's model wavefront aberrations.
(53) The design represented at
(54) Thus, in an alternative exemplary embodiment, the sag at
(55)
(56) In another alternative embodiment, the curvature and conic constant corresponding to the x direction may be different to that defining the tangential progression. Thus, the surface is represented by eq. 3:
(57)
where the cx and kx and cy and ky are the curvature and conic constant respectively in the x and y direction.
(58) The power progression concept herein described may be applied in orientations other than vertically. In an alternative embodiment, the results from the fitting corresponding to the sag of the power progression may also be used to generate an additional progression in the x direction, according to eq 4:
(59)
where the kix and kiy with i=1,8 are the results from the fitting representing the power progression in the x and y direction respectively with respect to the curvatures and conic constants cx and kx, and cy and ky respectively. Those skilled in the art may understand that the power progression applied in the x and y direction may be the same, fitted or not against the same base power, or may be different.
(60) In an exemplary embodiment, the progressive surface is generated by applying the power progression corresponding to
(61) The step progression which defines the sag at
(62) The minimum or maximum add power of the exemplary embodiment are merely illustrative. More particularly, the minimum add power may be greater than 0 Diopters, and/or the maximum add power may be less than or greater than +3 Diopters. For example, the minimum or maximum add power may be modified to provide a customized performance for near, intermediate or distance vision of the subject.
(63) Likewise, the point along the diameter at which the progression begins or ends may be modified, such as in order to customize performance of the optic. Moreover, multiple progressions may occur along the diameter, such as wherein a progression is implemented from 0 mm to 2.25 mm in the exemplary 6 mm diameter optic, the same or a different progression is implemented from 2.25 mm to 4.5 mm, and the same, or yet a different, progression is implemented from 4.5 mm to 6 mm. Similarly, one or all progressions may be uniform progressions, or may be non-uniform progressions, in order to customize the vision outcome by subject. The power addition progression may be displaced with respect the center of the optic.
(64) With reference to
(65) In the present example, the power addition progression is displaced with respect the center of the optic. By this way, pupil independence is addressed. It is important to note that the far focus should be clearly appreciable by the patient in order to avoid near dependent designs that could lead to confusion for the subject in the far focus finding during the refraction process, thus eliminating the multifocal effect of the optic.
(66)
(67) It will be appreciated that confining the add power progression to the central zone, in accordance with the present invention, may avoid significant pupil dependence. Further, the add power progression may avoid abrupt power changes that can lead to halos, glare and decreased contrast sensitivity, while being particularly beneficial for intermediate vision.
(68) Although an optical add power progression in accordance with the present invention may cause astigmatism, coma, and/or other aberrations, a customized simulation executed prior to implantation may allow for anticipation of such aberrations, and may indicate one or more design selections, as discussed herein, in order to maximize the optical performance of the coupling between the design and those aberrations added by the patient.
(69)
(70) More particularly, and as illustrated in
(71) The processor 302 may be embodied in a general purpose desktop or laptop computer, and/or may comprise hardware associated with biometric reader 301 specifically for selecting an IOL having an add power progression for placement into the eye of the subject. In certain embodiments, the system 300 may be configured to be electronically coupled to another device, such as one or more instruments for obtaining measurements of an eye or a plurality of eyes. Alternatively, the system 300 may be embodied in a handheld device that may be adapted to be electronically and/or wirelessly coupled to one or more other devices.
(72) Those of ordinary skill in the art may recognize that many modifications and variations of the present invention may be implemented without departing from the spirit or scope of the invention. Thus, it is intended that the present invention covers such modifications and variations of this invention provided they come within the scope of the discussion herein and any appended claims, and any equivalents thereto.